Completed

AXELProgram for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Drug Data

+ drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2011
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: March 23, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.

NCT01696695
Principal SponsorHoffmann-La Roche
Last updated: March 23, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

882 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

1 inclusion criteria required to participate
Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label
7 exclusion criteria prevent from participating
History of serious or unexpected reaction to fluoropyrimidine therapy
Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
Inadequate bone marrow, hepatic or renal function
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Szent Margit Hospital

Budapest, HungaryOpen Szent Margit Hospital in Google Maps

Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.

Budapest, Hungary

Semmelweis Egyetem, II. Belgyógyászati Klinika

Budapest, Hungary

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

Budapest, Hungary
Completed22 Study Centers